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Tutivia™ is a blood-based biomarker test to identify early in the patient’s posttransplant journey if acute
rejection is likely to be happening. It is a 17 gene mRNA signature derived from biological systems such as inflammatory response, cell repair and cell metabolism that are highly predictive of identifying rejection requiring clinical intervention. The test is for all forms of rejection but excludes other clinical issues such as BK Nephritis

How was Tutivia™ Studied?

Tutivia™ was studied as an independent prospective, multicenter (14 transplant sites), blinded, international trial that allowed for Actionable Data the inclusion of diverse populations and broad diversity in care management practices; while allowing blinding to protect from the introduction of biases; thereby producing robust and reliable results for clinical integration. The complexity of issues facing clinicians [real time] in their clinics was reflected as much as was possible in the study design. Diverse organ procurement in that there were organs usually excluded from trials in our data set, but reflects the available organs utilized to transplant patients.
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Actionable Data

All evaluable participants (n = 151, table 1) enrolled at 14 centers in 5 countries were included in the Tutivia™ validation. Each study participant had blood collected at the time of for-cause (n = 44) or protocol biopsy (n = 107) within the first 6 months following transplant. Each biopsy was read centrally by an expert in renal pathology to identify and characterize rejection phenotypes. In 151 unique patients, 46 (30%) rejection events were characterized according to current (2019) BANFF criteria, including borderline TCMR3. Mean time to rejection was 61.1 days; range: 6 - 175d. Additionally, BK Nephropathy was identified in 8 patients and pyelonephritis in 3 patients.

Tutivia™ risk scores are calculated continuously from 0-100; for interpretation, a pre-determined risk cut-point of 50 was established based on the independent training set1. The risk score distribution (fig. 1) resulted in 26.5% of patients with a high risk (>50) score result in which 60% were shown to correlate with rejection on histopathology; low risk score results in 73.5% of patients correlated with an absenceof rejection on histopathology findings in 80% of patients. The receiver operating characteristic curve AUC was 0.693, P<0.001.

Tutivia™ is a blood-based transcriptomic RNA expression signature that utilizes a proprietary
AI algorithm to assign a risk score for acute rejection with correlation to kidney biopsy, across
the entire BANFF 2019 histological continuum. Tutivia™ is able to assist the clinician in actionable
decisions, regarding treatment of kidney transplant patients at risk for acute rejection.